EUCTR2014-002722-13-FR进行中（未招募）1 期
Phase I/II feasibility study of Brentuximab Vedotin in refractory / relapsed Hodgkin lymphoma patients who are treated by chemotherapy (ICE) in second line and eligible for autologous transplantation - BV-ICE
YSARC0 个研究点目标入组 55 人开始时间: 2016年1月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histologically confirmed CD30+ HL, primarily
- •refractory to first line chemotherapy or in first relapse after any
- •polychemotherapy regimen
- •2. Measurable disease defined as at least one single node or tumor
- •lesion on CT scan > 1.5 cm
- •3. FDG-PET/ CT realized at relapse and positive.
- •4. Age = 18 years and up to 65 years
- •5. ECOG Performance Status = 2
- •6. Life expectancy of > 3 months with treatment
- •7. No major organ dysfunction, unless HL-related
- •8. Normal cardiac and pulmonary function for auto transplantation
- •9. Eligible for high dose chemotherapy and autologous peripheral
- •blood stem cell transplantation
- •10. Resolution of toxicities from first-line therapy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 55
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Peripheral sensory or motor neuropathy grade = 2
- •2. Any chemotherapy, radiotherapy, immunotherapy or
- •investigational, therapy for treatment of lymphoma within 28 days
- •3. Patient who have been treated by first line of treatment with
- •brentuximab vedotin alone or in combination
- •4. Female patients who are both lactating and breast feeding or
- •have a positive serum pregnancy test during the screening period
- •or a positive pregnancy test prior C1D1
- •5. Patients with active, uncontrolled infections (requiring systemic
- •antibiotics within two weeks prior to treatment
- •6. Prior history of another cancer unless the subject has been free
- •of the disease for = 3 years (with the exception of non-melanoma
- •skin cancer, completely resected melanoma TNMpT1 or
- •carcinoma in situ of the uterine cervix)
- •7. Known cerebral or meningeal disease (HL or any other etiology),
- •including signs or symptoms of PML
- •8. Patients with known HIV seropositivity, hepatitis B, hepatitis
- •C (Ag detection of HBs Antigen or presence of anti HBc
- •antibody without detectable anti HBs antibody)
- •9. Patients having received radiation therapy within 8 weeks prior
研究者
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已完成
不适用
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